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Androgen Biosynthesis Inhibitor

Abiraterone + Prednisone/Olaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Maha Hussain, MD, FACP, FASCO
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological proof of prostate adenocarcinoma (Note: small-cell carcinoma of the prostate is not permitted)
Agree to undergo a biopsy of at least one metastatic site (fresh biopsy of primary prostate only allowed if there is clear local disease and no other measurable disease site or biopsiable bone lesion.) to determine DNA repair defects. (Please refer to the Laboratory Manual for specific procedures). However:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group

Study Summary

This trial is testing a new cancer treatment for men with metastatic castration resistant prostate cancer. It is a 1:1:1 randomized open-label multicenter phase II study, which means that patients will be randomly assigned to one of three different treatment groups. The study will take place at multiple centers, and patients will be observed over the course of the trial.

Who is the study for?
Men with metastatic castration-resistant prostate cancer and specific DNA repair defects (like ATM, BRCA mutations) can join. They must have a life expectancy of at least 6 months, be able to take oral meds, agree to use contraception for 3+ months after the trial, and not have had certain treatments like CYP17 inhibitors or chemotherapy for resistant disease. No major surgery or uncontrolled medical issues within 14 days before joining.Check my eligibility
What is being tested?
The study is testing three approaches: Abiraterone/Prednisone alone, Olaparib alone, or both combined in men with advanced prostate cancer who have genetic changes affecting DNA repair. It's an open-label phase II trial where patients are randomly assigned to one of the treatment arms.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, low blood counts that could increase infection risk; liver problems; shortness of breath; rash; joint pain; high blood pressure and other heart-related issues. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.
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I agree to a biopsy to check for DNA repair defects in my cancer.
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I can take care of myself and am up and about more than half of the day.
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My organs are functioning well, as tested within the last 14 days.
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I agree to use contraception during and for 3 months after the study.
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I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.
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I can swallow pills without needing to break them down.
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I have recovered from any surgery or radiation therapy side effects.
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I am willing and able to follow the study's treatment plan and attend all visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Progression Free Survival (PFS)
Secondary outcome measures
Incidence of Adverse Events
Measurable disease response rate by RECIST
PSA response rate
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Arm I: Abiraterone + PrednisoneActive Control2 Interventions
Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.
Group II: Arm II: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Group III: Arm III: Abiraterone + Prednisone + OlaparibActive Control3 Interventions
Abiraterone 1000 mg orally once daily, prednisone 5 mg orally twice daily, olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Group IV: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,569 Previous Clinical Trials
909,143 Total Patients Enrolled
20 Trials studying Prostate Cancer
2,944 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,216 Previous Clinical Trials
289,737,451 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,488 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,730 Total Patients Enrolled
559 Trials studying Prostate Cancer
506,278 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Androgen Biosynthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03012321 — Phase 2
Prostate Cancer Research Study Groups: Arm I: Abiraterone + Prednisone, Arm II: Olaparib, Arm III: Abiraterone + Prednisone + Olaparib, Olaparib
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03012321 — Phase 2
Abiraterone Acetate (Androgen Biosynthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012321 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What diseases can be treated by the combination of Abiraterone and Prednisone in Arm I?

"Arm I: Abiraterone + Prednisone is traditionally indicated for ulcerative colitis, however it can also be utilized to treat illnesses such as varicella-zoster virus acute retinal necrosis and brain iritis."

Answered by AI

How many medical centers are conducting this experiment?

"Patients have the option to enroll in 15 different sites across the United States. This includes Chapel Hill, Charlottesville and Chicago as well as 12 other locations. To reduce travel demands, it is recommended that you select a location nearest your residence."

Answered by AI

What is the current sample size of this experimental research?

"As of August 28th, 2023, this trial is no longer recruiting. Originally posted on December 1st 2017, it has since been replaced by a selection of 1263 clinical trials for prostate cancer and 480 studies specifically testing Arm I: Abiraterone + Prednisone."

Answered by AI

Is an opportunity still available to participate in this experiment?

"This research is not currently accepting patients. Initially posted on 12th January 2017, and last modified on the 28th August 2023, there are a plethora of other clinical trials for prostate cancer (1263) and Arm I: Abiraterone + Prednisone (480)."

Answered by AI

Has there been any research conducted on the combination of Abiraterone and Prednisone in Arm I?

"Presently, Arm I: Abiraterone + Prednisone is being studied in 480 clinical trials. Of those, 109 are Phase 3 studies. Despite the majority of these experiments taking place in Rochester, Minnesota there are 24329 different sites that have been enrolled for this specific therapy."

Answered by AI

How can patients be assured of their safety when taking Arm I: Abiraterone + Prednisone?

"Arm I: Abiraterone + Prednisone's safety is assessed to be a 2 on the scale of 1 to 3 due to its Phase 2 status. While there are some data that suggest it is safe, no evidence has been provided as yet regarding its efficacy."

Answered by AI
~19 spots leftby Dec 2026